Effects of CHONDRON (Autologous Chondrocytes) With Ankle Cartilage Defect

Phase 3

Completed

Brief Summary: An open clinical trial transplanting CHONDRON (autologous chondrocytes) to ankle cartilage defect patients who are appropriate for the trial, and evaluating the validity and safety for 12 months.

Detailed Description: This clinical trial was designed to observe effects of CHONDRON (autologous chondrocytes) for 12 months in patients with ankle cartilage defects. In this clinical trial, 30 subjects were screened- 4 were excluded half way and 26 finished the trial. Full-thickness articular cartilage specimen was obtained from sites that do not have direct articulation within the ankle joint(anterior talus, anterior process of calcaneus, calcaneocuboid joint area.) Gel-type CHONDRON (Fibrin mixed Autologous chondrocytes) was transplanted at the defects. Evaluation variables were AOFAS, 100 mm VAS, HANNOVER score, self-assessment of improvement by the patient, MRI and arthroscopy.

Recruitment & Eligibility

Inclusion Criteria

adult men and women over 15 and less than 65 years of age
applied to patients with arthroscopically or grossly confirmed, partial cartilage defect at the ankle joint
patients with ankle-tibia malalignment of the ankle joint, unstable ankle ligaments, bone defects at the cartilage defect area or patients who received correction in advance.
patients which surrounding cartilage are normal
patients who agreed to clinical trial participation voluntarily or by the will of the person in parental authority, and signed the written consent form

Exclusion Criteria

patients hypersensitive to bovine protein
patients hypersensitive to gentamicin antibiotics
patients with inflammatory arthritis such as rheumatoid arthritis, gout arthritis
patients with arthritis related to autoimmune disease
pregnant, breast-feeding patients or those who have a possibility of pregnancy
patients with accompanying diseases other than articular cartilage defects, including tumors
patients who have a history of receiving radiotherapy, chemotherapy in the last 2 years
patients with diabetes (however, patients whose blood sugar test results are normal and do not have any complication of diabetes, when a written opinion that CHONDRON administration is possible is appended by a doctor are excluded)
patients who are administering antibiotics and antimicrobial agents due to infection
patients who receive steroid hormone therapy
Patients with psychiatric disorder and those who are considered to be inappropriate for this trial by the judgment of the clinical trial manager

Arm && Interventions

Group	Intervention	Description
Chondron implantation	Chondron(autologous chondrocyte) Implantation	ankle cartilage defect patients who had CHONDRON transplantation

Primary Outcome Measures

Name	Time	Method
Average Change From Baseline in American Orthopedic Foot and Ankle Society(AOFAS) at 12 Months Post-surgery	baseline(preoperative stage),12months post-surgery	AOFAS scores(best score-100,worst score- 0 ) 1. pain-none:40/Strong and Always present:O 2. Function * activities-without support activities:10/need restrain, clutch , walker or wheelchair:0 * Maximum gait distance- more than 6:5/ less than 1:0 * gait surface-easy in any surace:5/strong difficult in irregular ground stair or slopes:0 * Gait abnormality-none:8/marked:0 * saggital mobidity- normal or minimal restrain:6/strong restraint:0 * hindfoot mobidity -normal minimal restrain:6/strong restrain:0 * ankle and hindfoot stability - stable:8/unstable:0 3. alignment- good:10/bad:0

Secondary Outcome Measures

Name	Time	Method
Average Change From Baseline in 100mm Visual Analogue Scale(VAS) at 12months Post-surgery	baseline(preoperative stage),12months post-surgery	A VAS is a horizontal line, 100mm in length, anchored by word descriptors about pain at each end.The VAS is measured degree of pain from 0mm to 100mm. Severe pain is represented by 100mm and no pain is represented by 0mm. The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks. The difference of secondary evaluation variables VAS at baseline and after the end of the trial were analyzed by using paired t-test. Improvements were compared and analysis by each time point.
Average Change From Baseline in the Modified Hannover Scoring System at 12 Months Post Surgery	baseline(preoperative stage),12months post-surgery	The Modified Hannover Score System contains information about patient's status(pain-36, clinical finding- 4, patient's subjective assessment- 25, statics- 6, fuction- 26, radiology-7;best score-104, worst score-0).The scores of 27 patients in the FAS group were taken in the screening period (Visit S), 12 months after transplantation (Visit 7). The difference of the scores at screening and 12 months after transplantation was compared by using the paired t-test. Improvements were compared and analyzed at each time point.